Viral Vector

iCELLis® 500 Bioreactor

AGC Biologics develops and manufactures Lenti and Retro viral vectors. Our ready-to-use platform capabilities are built on cell factories (up to 48L) and bioreactors (up to 200L) using adherent processes, designed entirely in-house. Our quality systems, GMP manufacturing scale and regulatory qualification allow us to meet both clinical and commercial demand. Moreover, our scale down capabilities provide flexible and cost-effective solutions for process development and pre-clinical studies. Since we perform more than 100 analytical tests in-house, AGC Biologics reduces overall turnaround time. With experience manufacturing three commercial products, we are the only Cell & Gene Therapy (C&GT) CDMO that has brought its own product to the market (Zalmoxis®).

[

Tech Transfer & Process Development

  • Knowledge transfer from client to AGC Biologics
  • Feasibility studies for new processes with new reagents and materials
  • Ready-to-use Lenti viral vector manufacturing platforms with off-the-shelf materials (packaging plasmids, master cell bank)
  • Transfer of client processes at different development stages from R&D scale to cGMP
  • Small-scale setting up experiments for production of research and non-clinical batches
  • Small-scale run to certify the quality of the reagents (plasmid DNA, master cell bank, etc.)
  • Optimization studies to improve process performance
  • Pilot run to set and define the production methods
  • LPC and characterization studies
  • Comparability studies
  • Analytical development for potency and client specific assays
  • Qualification of product specific analytical methods before final transfer to QC
  • Implementation and optimization of automated assays
,

Up-Stream Process Development

  • Flexible scale of production in cell factories up to 48L
  • Flexible scale of production in bioreactors up to 200L
  • Single-use technologies
  • Extensive experience of developing in-house and optimizing client processes
    Production Scale
    • Petri Dishes
    • Cell Factory
    • Pall iCELLis® Nano system
    • Pall iCELLis® 500 system
,

Down-Stream Process Development

Separation Chromatography Techniques
  • Ion exchange
  • Size exclusion
  • Affinity
  • Ligands
Tangential Flow Filtration
  • Ultrafiltration
  • Diafiltration
,

In-House Analytical Methods Development

Potency Assay
  • Infectious Viral Titer
  • Physical Viral Titer
  • Infectivity
  • Transgene function
Identity and Chemical/Physical Characteristic
  • Vector Identity
  • pH
  • Osmolality
Purity
  • Residual BSA/HCP/BENZONASE
  • Lentiviral Proteins
  • Residual LTA protein
  • Residual VSV-G/LTA/E1A and Total DNA
Microbiological Control and Safety
  • Endotoxin
  • Sterility
  • Cultural RCL
,

cGMP Manufacturing & Quality Control

  • Ready-to-use in-house platform in cell factories up to 48L
  • Release, IPC, characterization and stability testing
  • Analytical method transfer
  • Method validation in accordance with relevant guidelines
  • Stability studies management (scheduling, testing, documentation and statistical analysis to support shelf life definition)
  • Characterization studies management
  • Outsourcing testing management
  • Raw materials release
,

Quality Assurance

  • Support with regards to regulatory submissions (IND, IMPD, BLA, MAA)
  • Integrated quality systems incorporating US, European, and ICH cGMP requirements
  • Comprehensive Quality Agreements
  • Regulatory compliance and validation expertise
  • History of successful client audits and regulatory inspections
  • EU cGMP Certification
]